CA2267104C - Heart volume limiting device - Google Patents
Heart volume limiting device Download PDFInfo
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- CA2267104C CA2267104C CA002267104A CA2267104A CA2267104C CA 2267104 C CA2267104 C CA 2267104C CA 002267104 A CA002267104 A CA 002267104A CA 2267104 A CA2267104 A CA 2267104A CA 2267104 C CA2267104 C CA 2267104C
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- heart
- cardiac
- biomedical material
- reinforcement device
- jacket
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2478—Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
- A61F2/2481—Devices outside the heart wall, e.g. bags, strips or bands
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
- A61M60/161—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel mechanically acting upon the outside of the patient's blood vessel structure, e.g. compressive structures placed around a vessel
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/20—Type thereof
- A61M60/247—Positive displacement blood pumps
- A61M60/253—Positive displacement blood pumps including a displacement member directly acting on the blood
- A61M60/268—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/40—Details relating to driving
- A61M60/465—Details relating to driving for devices for mechanical circulatory actuation
- A61M60/47—Details relating to driving for devices for mechanical circulatory actuation the force acting on the actuation means being mechanical, e.g. mechanically driven members clamping a blood vessel
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2478—Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
- A61F2/2481—Devices outside the heart wall, e.g. bags, strips or bands
- A61F2002/2484—Delivery devices therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having an inflatable pocket filled with fluid, e.g. liquid or gas
Abstract
The present disclosure is directed to a cardiac reinforcement device (CRD) and method for the treatment of cardiomyopathy. The CRD provides for reinforcement of the walls of the heart by constraining cardiac expansion, beyond a predetermined limit, during diastolic expansion of the heart. A CRD of the invention can be applied to the epicardium of the heart to locally constrain expansion of the cardiac wall or to circumferentially constrain the cardiac wall during cardiac expansion.
Description
HEART VOLUME LIMITING DEVICE
Background of the Invention The present invention is generally directed to a device and method for reinforcement of the cardiac wall. The invention is particularly suited for the treatment of cardiac disease which result in atrial or ventricular dilation.
The invention provides reinforcement of the cardiac wall during diastolic chamber filling to prevent or reduce cardiac dilation in patients known to have experienced such dilation or who have a predisposition for such dilation occurring in the future. The cardiac reinforcement structure is typically applied to the epicardial surface of the heart.
Cardiac dilation occurs with different forms of cardiac disease, including heart failure. In some cases, such as post-myocardial infarction, the dilation may be localized to only a portion of the heart. In other cases, such as hypertrophic cardiomyopathy, there is typically increased resistance to filling of the left ventricle with concomitant dilation of the left atria. In dilated cardiomyopathy, the dilation is typically of the left ventricle with, resultant failure of the heart as a pump. In advanced cases, dilated cardiomyopathy involves the majority of the heart.
With each type of cardiac dilation, there are associated problems ranging from arrhythmias which arise due to the: stretch of myocardial cells, to leakage of the cardiac valves due to enlargemer.~t of the valvular annulus.
Devices to prevent or reduce dilation and thereby reduce the consequences of dilation have not been described. Patches made from low porosity materials, for example DacronTM, have been used to repair cardiac ruptures and se;ptal defects, but the use of patches to support the cardiac wall where no penetrating lesion is present has not been described.
Drugs are sometimes employed oo assist in treating problems associated with cardiac dilation. For example, digoxin increases the contractility of the cardiac muscle and thereby causes enhanced emptying of the dilated cardiac chambers. On the other hand, some drugs, for example, beta-blocking drugs, decrease the contractility of the heart and thus increase the likelihood of dilation.
Other drugs including angiotensin-converting enzyme inhibitors such as enalopril help to reduce the tendency of the heart to dilate: under the increased diastolic pressure experienced when the contractility of the heart muscle decreases.
Many of these drugs, however, have side effects which make them undesirable for long-term use.
Accordingly, there is a need for a device that can reduce or prevent cardiac dilation and reduce the problems associated with such dilation.
Background of the Invention The present invention is generally directed to a device and method for reinforcement of the cardiac wall. The invention is particularly suited for the treatment of cardiac disease which result in atrial or ventricular dilation.
The invention provides reinforcement of the cardiac wall during diastolic chamber filling to prevent or reduce cardiac dilation in patients known to have experienced such dilation or who have a predisposition for such dilation occurring in the future. The cardiac reinforcement structure is typically applied to the epicardial surface of the heart.
Cardiac dilation occurs with different forms of cardiac disease, including heart failure. In some cases, such as post-myocardial infarction, the dilation may be localized to only a portion of the heart. In other cases, such as hypertrophic cardiomyopathy, there is typically increased resistance to filling of the left ventricle with concomitant dilation of the left atria. In dilated cardiomyopathy, the dilation is typically of the left ventricle with, resultant failure of the heart as a pump. In advanced cases, dilated cardiomyopathy involves the majority of the heart.
With each type of cardiac dilation, there are associated problems ranging from arrhythmias which arise due to the: stretch of myocardial cells, to leakage of the cardiac valves due to enlargemer.~t of the valvular annulus.
Devices to prevent or reduce dilation and thereby reduce the consequences of dilation have not been described. Patches made from low porosity materials, for example DacronTM, have been used to repair cardiac ruptures and se;ptal defects, but the use of patches to support the cardiac wall where no penetrating lesion is present has not been described.
Drugs are sometimes employed oo assist in treating problems associated with cardiac dilation. For example, digoxin increases the contractility of the cardiac muscle and thereby causes enhanced emptying of the dilated cardiac chambers. On the other hand, some drugs, for example, beta-blocking drugs, decrease the contractility of the heart and thus increase the likelihood of dilation.
Other drugs including angiotensin-converting enzyme inhibitors such as enalopril help to reduce the tendency of the heart to dilate: under the increased diastolic pressure experienced when the contractility of the heart muscle decreases.
Many of these drugs, however, have side effects which make them undesirable for long-term use.
Accordingly, there is a need for a device that can reduce or prevent cardiac dilation and reduce the problems associated with such dilation.
EP-A-0 280 564 describes defibrillation elec-trodes which may be placed over a portion of a heart, the electrodes being spaced from one another to avoid shunting of current between them upon delivery of defibrillation shocks.
Summary of the Invention The present invention is directed to a device and method for reinforcement of the cardiac wall.
According to the present invention, there is provided a cardiac reinforcement device comprising:
(a) a biomedical material having an apical end and a based end and which generally conforms to the external geometry of a patient's heart;
(b) said biomedical material being elastic and comprising a plurality of open cells, each open cell defined by multiple sides, each open cell sharing at least one of said multiple sides with an adjacent open cell; and (c) said biomedical material being a size selected to surround the surface of the heart and constrain cardiac expansion.
Preferably the cone-shaped biomedical material may be substantially non-elastic.
Preferably, the cone-shaped biomedical material may have a lateral slot providing for selective adjustment of a circumference of said cone-shaped biomedical material to said predetermined size.
The apical end of said device may be open.
The biomedical material may be a polyester mesh.
2a Preferably, the base end of the cone-shaped bio-medical material may include a securing arrangement for securing said device to said patient's heart.
Preferably, the cardiac reinforcement device may further comprise an inflatable member sized for selectively adjusting said predetermined size of said cone-shaped bio-medical material, said inflatable member sized for positioning between said device and said patient's heart.
According to the present invention, there is also provided a cardiac reinforcement device for constraining cardiac size during diastole, said device comprising:
(a) an elastic biomedical material for contacting an epicardial surface of a patient's heart and configured to circumferentially surround said epicardial surface of said patient's heart;
(b) said configured biomedical material having a base end and an apical end and formed into a jacket to surround the heart with said jacket having an internal volume to receive said heart;
(c) said elastic biomedical material comprising a continuous mesh construction, said continuous mesh construction defining a plurality of open cells; and (d) said configured biomedical material providing cardiac constraint during diastole without substantially assisting cardiac contraction during systole.
According to the present invention, there is also provided a cardiac reinforcement device for treating a cardiac condition, said device comprising:
(a) a synthetic biomedical material having interconnected sides with a predetermined maximum spacing between said 2b sides which can be disposed on diametrically opposed surfaces of a heart;
(b) said synthetic biomedical material comprising an elastic, continuous mesh construction, said continuous mesh construction defining a plurality of open cells;
(c) said biomedical material having a base end and an apical end; and (d) said biomedical material providing cardiac constraint during diastole without substantially assisting cardiac contraction during systole.
According to the present invention, there is also provided a cardiac reinforcement device, said device comprising:
a jacket of a biomedical material which can be applied to the epicardial surface of the heart and which expands to a size to surround the epicardial surface of the heart and circumferentially constrain cardiac expansion, said jacket comprising:
i) a base end, said base end having an opening for applying said jacket to the epicardial surface of the heart by passing said jacket over the epicardial surface of the heart such that when applied to said epicardial surface, said base end of said jacket is oriented toward the base of the heart; and ii) a slot for selectively adjusting said size of said jacket, said slot having opposing lateral edges which decrease said size of said jacket by moving said opposing lateral edges together.
According to the present invention, there is also provided a cardiac reinforcement device, said device comprzslng:
2c a jacket of an open mesh biomedical material which can be applied to the epicardial surface of the heart and which expands to a size to surround the epicardial surface of the heart and circumferentially constrain cardiac expansion, said jacket comprising:
i) a base end, said base end having an opening for applying said jacket to the epicardial surface of the heart by passing said jacket over the epicardial surface of the heart such that when applied to said epicardial surface, said base end of said jacket is oriented toward the base of the heart; and ii) an inflatable member mounted between said jacket and the epicardial surface of the heart for selectively adjusting said size of said jacket.
According to the present invention, there is also provided an arrangement for placing a cardiac reinforcement device onto a heart comprising:
a cardiac reinforcement device, said cardiac reinforcement device comprising:
i) a biomedical material which can be applied to a surface of said heart and having a size selected to constrain cardiac expansion, said cardiac reinforcement device configured into a jacket, said jacket having an open base end and an apex end;
a placement tool for maintaining said open base end in a configuration for passing said open base end over said surface of said heart.
According to the present invention, there is also provided a system for cardiac reinforcement comprising:
a cardiac reinforcement device comprising:
rs 2d (a) a biomedical material having an apical end and a base end and which generally conforms to an external geometry of a patient's heart;
(b) said biomedical material comprising a plurality of open cells, each open cell defined by multiple sides, each open cell sharing at least one of said multiple sides with an adjacent open cell;
(c) said biomedical material having a size selected to surround said external geometry of said heart and constrain cardiac expansion; and a placement tool for maintaining said base end of said cardiac reinforcement device in an open position for passing said cardiac reinforcement device over said external geometry of said heart.
According to the present invention, there is also provided a cardiac reinforcement device for constraining outward expansion of a heart wall of a patient's heart during diastole, said device comprising:
(a) a biomedical material having an apical end and a base end and which generally conforms to an external geometry of said patient's heart;
(b) said biomedical material being elastic and having a compliance lower than a compliance of said heart wall;
(c) said biomedical material comprising a size selected to surround an external surface of said heart and constrain cardiac expansion during diastole.
According to the present invention, there is also provided a cardiac reinforcement device for constraining cardiac size during diastole, said device comprising:
(a) an elastic biomedical material for contacting an epicardial surface of a patient's heart and configured to 2e circumferentially surround said epicardial surface of said patient's heart;
(b) said biomedical material comprising a plurality of open cells, each open cell defined by multiple sides, each open cell sharing at least one of said multiple sides with an adjacent cell;
(c) said configured biomedical material having a base end and an apical end and formed into a jacket to surround said heart with said jacket having an internal volume to receive said heart;
(d) said configured biomedical material being less compliant than a wall of said heart; and (e) said configured biomedical material providing cardiac constraint during diastole without substantially assisting cardiac contraction during systole.
According to the present invention, there is also provided a cardiac reinforcement device, said device comprising:
(a) a jacket of a biomedical material which can be applied to an epicardial surface of a patient's heart and which expands to a size selected to surround said epicardial surface of said heart and circumferentially constrain cardiac expansion, said jacket comprising:
i) a base end, said base end having an opening for applying said jacket to said epicardial surface of said heart by passing said jacket over said epicardial surface of said heart such that when applied to said epicardial surface, said base end of said jacket is oriented toward a base of said heart; and ii) said biomedical material being elastic and having a compliance less than a wall of said heart.
2f According to the present invention, there is also provided a cardiac reinforcement device for constraining cardiac size during diastole, said device comprising:
(a) a biomedical material for contacting an epicardial surface of a patient's heart and configured to circumferentially surround said epicardial surface of said patient's heart;
(b) said biomedical material comprising a plurality of open cells, each open cell defined by multiple sides, each open cell sharing at least one of said multiple sides with an adjacent cell;
(c) said configured biomedical material having a base end and an apical end and formed into a jacket to surround said heart with said jacket having an internal volume to receive said heart;
(d) said configured biomedic-al material being elastic; and (e) said configured biomedical material providing cardiac constraint during diastole without substantially assisting cardiac during systole.
According to the present invention, there is also provided a passive cardiac reinforcement device for constraining outward expansion of a heart wall of a patient's heart during diastole, said device comprising:
(a) a jacket constructed from a biomedical material, said jacket having an apical end and a base end and a size selected to surround an external surface of said heart and constrain cardiac expansion during diastole without substantially assisting cardiac contraction during systole;
and (b) a marker for evaluating cardiac performance.
2g According to another aspect of the present inven-tion, there is provided a method for treating cardiac disease, said method comprising:
(a) selecting a cardiac reinforcement device, said cardiac reinforcement device comprising:
i) a substantially non-elastic biomedical material which can be applied to an epicardial surface of said heart and having a maximum predetermined size, said predetermined size selected to constrain cardiac expansion beyond a predetermined limit;
ii) said substantially non-elastic biomedical material comprising a plurality of continuous strands of said biomedical material, said strands defining a plurality of open cells;
(b) applying said cardiac reinforcement device to said surface of said heart by applying said device to dia-metrically opposite sides of said heart and with opposite sides of said biomedical material overlying said opposite sides of said heart interconnected to one another; and (c) securing said cardiac reinforcement device to said surface of said heart with said opposing sides urged together by a spacing less than an unconstrained diastolic expansion of said diametrically opposite sides of said heart.
According to another aspect of the present inven-tion, there is provided a method for treating cardiac disease, said method comprising:
(a) selecting a cardiac reinforcement device, said cardiac reinforcement device comprising:
i) a synthetic biomedical material which can be applied to an epicardial surface of a patient's heart and 2h having a maximum pre-determined size, said predetermined size selected to constrain cardiac expansion beyond a predetermined limit;
ii) said synthetic biomedical material compri-sing a continuous mesh construction, said continuous mesh construction defining a plurality of open cells;
iii) said synthetic biomedical material formed into a jacket to surround said heart with said jacket having an internal volume to receive said heart;
(b) applying said cardiac reinforcement device to said surface of said heart; and (c) securing said cardiac reinforcement device to said surface of said heart with said jacket adjusted for said internal volume to assume said maximum predetermined size.
According to another aspect of the present invention, there is provided a method for reducing dias-tolic volume of a patient's heart, said method comprising:
(a) selecting a cardiac reinforcement device, said cardiac reinforcement device comprising:
i) a substantially non-elastic biomedical material which can be applied to an epicardial surface of said heart and having a maximum predetermined size, said predetermined size selected to constrain cardiac expansion beyond a predetermined limit, said cardiac reinforcement device configured into a jacket, said jacket having an open base end and an apical end;
(b) mounting said cardiac reinforcement device to a place ment tool which maintains said open base end in a configuration for passing said open base end over said epicardial surface of said heart;
2i (c) applying said cardiac reinforcement device to said surface of said heart; and (d) securing said cardiac reinforcement device to said epicardial surface of said heart.
According to another aspect of the present inven-tion, there is provided a method for minimally invasive treatment of cardiac disease of a patient's heart, said method comprising:
(a) making a first and second minimally invasive incision into said patient's thorax;
(b) passing a thorascope into said first incision for intra-thoracic visualization;
(c) passing a cannula into said second incision to a posi-tion for applying a cardiac reinforcement device to said patient's heart, wherein said cardiac reinfor-cement device comprises:
i) a biomedical material which can be applied to an epicardial surface of said heart and having a maximum predetermined size, said predetermined size selected to surround said surface of said heart and circumferentially constrain cardiac expansion beyond a predetermined limit;
(d) applying said cardiac reinforcement device to said epicardial surface of said patient's heart;
(e) removing said thorascope from said patient's thorax;
(f) closing said first and said second incisions in said patient's thorax.
A cardiac reinforcement device of the invention can be used to treat cardiomyopathy or to reduce the dias-tolic volume of the heart.
2j Brief Description of the Drawings FIG.1 is a frontal view of one embodiment of a cardiac reinforcement patch.
FIG.2 is a perspective view of the cardiac reinforcement patch of Fig.l in place on the epicardium of a heart.
FIG.3 is a perspective view of one embodiment of a cardiac reinforcement jacket according to the invention.
WO 98!14136 PCT/US97/17898 FIG. 4 is a second embodiment of a cardiac reinforcement jacket according to the invention.
FIG. 5 is a perspective view of the embodiment of the cardiac reinforcement jacket shown in FIG. 3 in place aground the heart.
FIG. 6 is a schematic cross sectional view of one embodiment of a mechanism for selectively adjusting the predete;rmined size of a cardiac reinforcement jacket.
FIG. 7 is a perspective view of a, placement tool which can be used for applying a cardiac reinforcement jacket.
FIG. 8 is a perspective view of a. placement tool being employed to place a cardiac reinforcement jacket over the he;art.
Detailed Descri i n The present invention is directed to reinforcement of the heart wall during diastolic filling of a chamber of the heart. The invention is particularly suited for use in cardiomyopathies where abnormal dilation of one or more chambers of the heart is a component of the disease.
As used herein, "cardiac chamber" refers to the left or right atrium or the left or right ventricle. The term "myocardium" refers to the cardiac muscle comprising the contractile walls of the heart. The term "endocardial surface"
refers to the inner walls of the heart. The term "epicardial surface" refers to the outer walls of the heart.
The heart is enclosed within a double walled sac known as the pericardium. The inner layer of the pericardial sac is the visceral pericardium or epicardium. The outer layer of the pericardial sac is the parietal pericardium.
According to the present invention, a cardiac reinforcement device (CRD) limits the outward expansion of the hea~~t wall during diastolic chamber filling beyond a predetermined size. The expansion constraint applied to the heart by a CRD is predetermined by the physician based on, for example, cardiac output performance or cardiac volume. In contrast to known ventricular assist devices which provide cardiac assistance during systole, a CRD according to the present disclosure provides cardiac reinforcement during diastole.
A CRD is made from a biomedical material which can be applied to the epicardial surface of the heart. As used herc;in, a "biomedical material"
is a material which is physiologically inert to avoid rejection or other negative inflammatory response. A CRD can be prepared from an elastic or substantially non-elastic biomedical material. The biomedical material can be inflexible, but is preferably sufficiently flexible to move with the; expansion and contraction of the heart without impairing systolic function. The biomedical material should, however, constrain cardiac expansion, during diastolic filling of the heart, to a predetermined size. Examples of suitable biomedical materials include perforate and non-perforate materials. Perforate materials include, for example, a mesh such as a polypropylene or polyester mesh. Non-perforate materials include, for example, silicone rubber.
A biomedical material suitable for a device of the invention generally has a lower compliance than the heart wall. Even though the biomedical material is less compliant than the heart wall, some limited expansion of an elastic biomedical material can occur during cardiac filling.
In an alternative embodiment, the biomedical material can be substantially non-elastic. According to this embodiment, the term "substantially non-elastic" refers to a material which constrains cardiac expansion during diastole at a predetermined size, but which has substantially no elastic properties.
Regardless if the biomedical material is elastic or non-elastic, advantageous to a CRD according to the present disclosure is cardiac reinforcement which is provided during diastole. Moreover, a CRD as disclosed herein does not provide cardiac assistance through active pumping of the heart.
I. CRD Patch In one embodiment, a cardiac reinforcement device (CRD) provides for local constraint of the heart wall during cardiac expansion. According to this embodiment, a CRD is a "patch" that provides reinforcement of the heart wall at a localized area, such as a cardiac aneurysm or at an area of the myocardium which has been damaged due to myocardial infarction. When discussing a "patch", "predetermined size" of the patch means that the size of the patch is selected to cover an area of the epicardial surface of the heart in need of reinforcement without completely surrounding the circumference of the heart.
A CRD patch can be prepared from the biomedical materials described above. In a preferred embodiment, the patch is an open mesh material.
A CRD patch can be applied to the epicardial surface of the heart over or under the parietal pericardium. A patch is typically applied to the epicardial surface by suturing around the periphery of the patch. The peripheral edge of the patch can include a thickened "ring" or other reinforcement to enhance the strength of the patch at the point of suture attachment to the epicardium. Generally, a patch is applied to the epicardium through a thoracotomy or other incision providing sufficient exposure of the heart.
WO 98/14136 PCTlUS97/17898 II. CRD Jacket In another embodiment, a CRD is a jacket that circumferentially surrounds the epicardial surface of the heart. V~Jhen applied to the heart, a CRD
jacket can be placed over or under the parietal pericardium.
A CRD applied to the epicardimn is fitted to a "predetermined size"
for limitation of cardiac expansion. According to a jacket embodiment, "predetermined size" refers to the predetermined expansion limit of the jacket which circumferentially constrains cardiac expansion during diastolic filling of the heart.
In practice, for example, a physician could measure cardiac output and adjust the jacket size to an optimal size for the desired effect. In this example, the optimal size is the "predetermined size". In one embodiment, the predetermined size can be adjusted for size reduction as the cardiac size is, reduced.
In one embodiment, the CRD jacket is a cone-shaped tube, having a base broader than the apex, which generally conforms to the external geometry of the heart. When applied to the epicardial surface of the heart, the base of the jacket is oriented towards the base of the heart, and the apex of the jacket is oriented towards the apex of the heart. Typically, the base of the jacket includes an opening for applying the jacket by passing the jacket over the epicardial surface of the heart.
The apical end of the jacket can be a continuous surface which covers the apex of the heart. Alternatively, the apex of the jacket can have an opening through which the apex of the heart protrudes.
A cardiac reinforcement jacket, .as disclosed herein, is not an inflatable device that surrounds the heart. Rather, the device is typically a single layer of biomedical material. In one embodiment discussed below, an inflatable member can be included with the device, but the inflatable member serves to reduce the volume within a localized region of the jacket and does not follow the entire jacket to surround the epicardial surface of the heart.
In one embodiment, the CRD jacket can be secured to the epicardium by a securing arrangement mounted at the base of the jacket. A suitable securing arrangement includes, for example, a circumferential attachment device, such as a cord, suture, band, adhesive or shape memory element which passes around the circumference of the base of the jacket. The ends of the attachment device can be fastened together to secure the jacket in place. Alternatively, the base of the jacket can be reinforced for suturing the base of the jacket to the epicardium.
Various sized CRD jackets can be prepared such that different sized jackets are used for different predetermined cardiac expansion sizes or expansion ranges. Alternatively, a CRD jacket can include a mechanism for selectively adjusting the size of the jacket. A mechanism for selectively adjusting the volumetric size of the jacket theoretically provides for a "one size fits all"
device.
More importantly, however, an adjustable jacket provides the ability to titrate (readjust) the amount of cardiac reinforcement by graded reduction in jacket size as therapeutic reduction of cardiac expansion occurs.
A mechanism for selectively adjusting the size of the jacket can include a slot which opens at the base of the jacket and extends toward the apex end of the CRD. If the apex end of the CRD jacket is open, the apical extent of the slot can be continuous with the apex opening. The slot includes opposing lateral edges.
By adjusting the proximity of the opposing lateral edges, the overall size of the jacket can be varied. Moving the opposing edges of the slot closer together narrows the slot and reduces the volumetric size of the jacket. The opposing edges of the slot can be fastened together at a predetermined proximity by, for example, one or more lateral attachment devices, such as a cord, suture, band, adhesive or shape memory element attached to each lateral edge.
In another embodiment, a mechanism for selectively adjusting the size of the jacket can be an inflatable member. According to this embodiment, the inflatable member is mounted between the jacket and the epicardium. The volumetric size of the jacket can be reduced by inflating the inflatable member through an inflation port with, for example, a gas or liquid. As cardiac expansion volume responds to cardiac constraint by size reduction, the predetermined size of the jacket can then be reduced by inflating the inflatable member within the jacket.
Once inflated, the size of the inflatable member is preferably maintained until therapeutic response causes a need for further inflation. According to the invention, the inflation of the inflatable member provides a reduction in the predetermined size of the jacket by a fixed increase in volume of the inflatable member. The inflatable member is not rhythmically inflated and deflated to provide assistance to cardiac contraction during systole.
The biomedical material of the invention can be radioluscent or radiopaque. In one embodiment, the material of the jacket can be made radiopaque by inclusion of radiopaque markers for identification of the outside surface of the heart, the expansion slot or inflation port. As used herein, radiopaque means causing the CRD to be visible on x-ray or fluoroscopic viewing. Suitable radiopaque markers include, for example, platinum wires, titanium wires and stainless steel cores.
A CRD according to the present disclosure provides a new method for the treatment of cardiac disease. As used herein, cardiac disease includes diseases in which dilation of one of the chambers of the heart is a component of the disease. Examples include heart failure or cardiomyopathy. Heart failure can occur as a result of cardiac dilation due to ventricular hypertrophy or secondary to, for example, valvular incompetency, valvular insufficiency or valvular stenosis.
Cardiomyopathy, according to the invention, can be primary or secondary to infection, ischemia, metabolic disease, genetic disorders, etc.
It is foreseen that constraint of c~~rdiac expansion by a device of the invention can provide reduced cardiac dilation. Reduced cardiac dilation can cause reduction in the problems associated with cardiac dilation such as arrhythmias and valvular leakage. As reduction of cardiac dilation occurs, selective reduction of the predetermined size of the jacket also provides continued reinforcement for the size reduced heart.
A CRD jacket can also be used to measure cardiac performance.
According to this embodiment, the CRD jacket is rendered radiopaque by use of a radiographic marker. The radiographic markers are distributed throughout the jacket over the surface of the heart. By evaluation of the markers relative to one another with each heart beat, cardiac performance may be measured. As such, evaluation of cardiac performance may assist in adjusting the predetermined size of a CRD
jacket.
A CRD as described herein can be applied to the epicardium of a heart through a thoracotomy or through a minirr.~ally invasive procedure. For a minimally invasive procedure a CRD placement: tool can be used to apply the CRD
over the epicardium of the heart through a thorascopic incision. According to this embodiment, a CRD placement tool includes a c;annula, a stiff rod or wire and a guide tube. For placement of a CRD, the wire is threaded through the guide tube which is passed around the circumference of the base of the jacket. The CRD
with wire and guide tube passed through the base opening are then passed into the cannula. The cannula is of sufficient length and diameter to enclose the CRD, wire and guide tube during passage of the placement tool through a thorascopic incision.
The placement tool is passed into the thoracic cavity and positioned at a point near the apex of the heart. When in position, the wire and guide tube are pushed out of the cannula away from the operator. Once outside the cannula, the wire and guide tube sufficiently expand the opening of the base of the CRD jacket to pass over the epicardial surface of the heart. When the CRD jacket is in position over the epicardial surface, the wire, guide tube and cannula can be removed. A second incision can then be made to provide access for ;suitable surgical instruments to secure or adjust the size of the CRD.
The invention will now be further described by reference to the drawings.
FIG. I is a frontal view of one embodiment of a cardiac reinforcement patch 1. The CRD patch 1 shown. here is a mesh biomedical material 2 having a thickened peripheral ring 3 which reinforces the peripheral edge 4 of the patch for attachment of the patch to the epicardial surface of the heart.
FIG. 2. is a perspective view of a CRD patch 10 in place on the epicardial surface of a heart 11, for example, over a cardiac aneurysm (not shown) of the heart. In one preferred embodiment, the patch 10 is sized to cover the extent of the cardiac aneurysm and is placed on the epicardial surface of the heart 11.
In practice, the thorax is surgically opened and the region of the heart 11 with the aneurysm (not shown) is located and exposed. The patch 10 is placed over the aneurysm and sutured in place around the periphery 12 of the patch to provide sufficient constraint to prevent further dilation of the aneurysm.
FIG. 3 is a perspective view of one embodiment of a CRD jacket 15 according to the invention. According to the embodiment shown, the jacket 15 is a mesh material 16, and includes a circumferential attachment device 17 at the base end 18 of the CRD jacket. The apex end 24 of the jacket 15 is closed. The jacket 15 shown also includes a slot 19 having opposing lateral edges 20 and 21, and fasteners (e.g. lateral attachment device 22 and 23) for selectively adjusting the volumetric size of the jacket 15. The CRD jacket 15 shown also includes radiopaque markers for visualizing the surface of the heart through radiographic study.
FIG. 4 is an alternative embodiment of a CRD jacket 30. Similar to 20 the embodiment shown in FIG. 3, the embodiment of FIG. 4 includes a base end 31 and an apex 32 end. The base end includes a circumferential attachment device for securing the CRD jacket 30 to the heart. The CRD jacket 30 of FIG. 4 also includes a slot 34 having opposing lateral edges 35, 36. The lateral edges 35, 36 are shown pulled together at 37 by a lateral attachment device 38, for example, a suture.
25 In contrast to the embodiment shown in FIG. 3, the embodiment shown in FIG.
has an opening 39 at the apex end 32 of the CRD jacket 30.
FIG. 5. is a perspective view of a CRD jacket 40 around a heart 41.
According to the embodiment shown, at the base 42 of the jacket 40, there is a circumferential attachment device 43 which secures the CRD jacket 40 near the base of the heart 44. A slot 45, is shown with opposing lateral edges 46, 47 fastened together by a lateral attachment device 48. In the embodiment shown, the CRD
jacket 40 has an opening 49 at the apical end 50 of the jacket. The apex of the heart 51 protrudes through the opening 49 at the apical end 50 of the jacket 40.
Still referring to FIG. S, in a preferred embodiment, if one or more of the lateral attachment device 48 are made of an elastic material, such as silicone rubber, the device can provide a way of applying a graded constraint around the outside of the heart 41 to reduce cardiac dilation over time. In practice, the jacket would be placed over the heart 41 as shown, either over or under the parietal pericardium (not shown). The circumferential attachment device 43 and lateral attachment device 48 would then be tightened to cause a constraining effect on the outside of the heart.
In a preferred embodiment, if one or more of the lateral attachment cords 48 is made of an elastic material, such as silicone rubber, surface pressure exerted on the epicardial surface of the heart v~u-ies as a function of the amount of dilation of the heart. This variable pressure ha;~ the effect of reducing the cardiac dilation to a certain point and then stopping because the surface pressure drops to a negligible amount. The amount of constraint or reduction in dilation that is accomplished over time and the resultant cardiac performance may be monitored radiographically using techniques known in the: art, for example fluoroscopy, by observing radiographic markers (FIG. 4, 25), if' present.
FIG. 6 is a schematic cross sectional view of an alternative embodiment of an arrangement for selectively adjusting the predetermined size of a jacket 53. According to this embodiment, an inflatable member 54 is inserted within the jacket 53 between the jacket 53 and the epi<;ardial surface 55 of the heart 56.
The inflatable member 54 includes a filling apparatus 57 for entry of a fluid (liquid or gas) to inflate the inflatable member 54 and reduce the predetermined size of the jacket 53.
FIG. 7 is a perspective view of a. placement tool 60 which can be used for placement of a CRD jacket 61 around the epicardium of the heart. As shown here, the base end of the jacket 62 is held open by guide tube 63 through which is passed a wire or stiffening rod 64. The wire 64 can be removed from the guide tube 63 by pulling on the wire extraction grip 66. The placement tool 60 includes a cannula 65 which encloses the jacket 61, guide tube 63 and wire 64 during insertion of the tool into a thorascopic incision.
FIG. 8 is a perspective view of a placement tool 70 being employed to place a jacket 71 over the heart 72 on the outside of the parietal pericardium 73.
The placement tool 70 is guided through a small incision in the thorax and the jacket 71 is maneuvered into position over the heart 72. Once the jacket 7i is in proper position, the wire 74, which is passed through tl:~e guide tube 75 around the base 76 of the jacket 71, is extracted from the guide tube 75 by pulling on the wire extraction grip 77. The guide tube 75 is then extracted by pulling on the guide tube extraction grip 78. The cannula 79 is removed from the chest and the circumferentiai attachment cord (not shown in this view), and the lateral attachment cord 80 can be fastened to secure the jacket 71.
The above specification and drawings provide a description of a cardiac reinforcement device and method of using on the heart. Since many embodiments of the invention can be made without departing from the spirit and scope of the invention, the invention resides in the claims hereinafter appended.
Summary of the Invention The present invention is directed to a device and method for reinforcement of the cardiac wall.
According to the present invention, there is provided a cardiac reinforcement device comprising:
(a) a biomedical material having an apical end and a based end and which generally conforms to the external geometry of a patient's heart;
(b) said biomedical material being elastic and comprising a plurality of open cells, each open cell defined by multiple sides, each open cell sharing at least one of said multiple sides with an adjacent open cell; and (c) said biomedical material being a size selected to surround the surface of the heart and constrain cardiac expansion.
Preferably the cone-shaped biomedical material may be substantially non-elastic.
Preferably, the cone-shaped biomedical material may have a lateral slot providing for selective adjustment of a circumference of said cone-shaped biomedical material to said predetermined size.
The apical end of said device may be open.
The biomedical material may be a polyester mesh.
2a Preferably, the base end of the cone-shaped bio-medical material may include a securing arrangement for securing said device to said patient's heart.
Preferably, the cardiac reinforcement device may further comprise an inflatable member sized for selectively adjusting said predetermined size of said cone-shaped bio-medical material, said inflatable member sized for positioning between said device and said patient's heart.
According to the present invention, there is also provided a cardiac reinforcement device for constraining cardiac size during diastole, said device comprising:
(a) an elastic biomedical material for contacting an epicardial surface of a patient's heart and configured to circumferentially surround said epicardial surface of said patient's heart;
(b) said configured biomedical material having a base end and an apical end and formed into a jacket to surround the heart with said jacket having an internal volume to receive said heart;
(c) said elastic biomedical material comprising a continuous mesh construction, said continuous mesh construction defining a plurality of open cells; and (d) said configured biomedical material providing cardiac constraint during diastole without substantially assisting cardiac contraction during systole.
According to the present invention, there is also provided a cardiac reinforcement device for treating a cardiac condition, said device comprising:
(a) a synthetic biomedical material having interconnected sides with a predetermined maximum spacing between said 2b sides which can be disposed on diametrically opposed surfaces of a heart;
(b) said synthetic biomedical material comprising an elastic, continuous mesh construction, said continuous mesh construction defining a plurality of open cells;
(c) said biomedical material having a base end and an apical end; and (d) said biomedical material providing cardiac constraint during diastole without substantially assisting cardiac contraction during systole.
According to the present invention, there is also provided a cardiac reinforcement device, said device comprising:
a jacket of a biomedical material which can be applied to the epicardial surface of the heart and which expands to a size to surround the epicardial surface of the heart and circumferentially constrain cardiac expansion, said jacket comprising:
i) a base end, said base end having an opening for applying said jacket to the epicardial surface of the heart by passing said jacket over the epicardial surface of the heart such that when applied to said epicardial surface, said base end of said jacket is oriented toward the base of the heart; and ii) a slot for selectively adjusting said size of said jacket, said slot having opposing lateral edges which decrease said size of said jacket by moving said opposing lateral edges together.
According to the present invention, there is also provided a cardiac reinforcement device, said device comprzslng:
2c a jacket of an open mesh biomedical material which can be applied to the epicardial surface of the heart and which expands to a size to surround the epicardial surface of the heart and circumferentially constrain cardiac expansion, said jacket comprising:
i) a base end, said base end having an opening for applying said jacket to the epicardial surface of the heart by passing said jacket over the epicardial surface of the heart such that when applied to said epicardial surface, said base end of said jacket is oriented toward the base of the heart; and ii) an inflatable member mounted between said jacket and the epicardial surface of the heart for selectively adjusting said size of said jacket.
According to the present invention, there is also provided an arrangement for placing a cardiac reinforcement device onto a heart comprising:
a cardiac reinforcement device, said cardiac reinforcement device comprising:
i) a biomedical material which can be applied to a surface of said heart and having a size selected to constrain cardiac expansion, said cardiac reinforcement device configured into a jacket, said jacket having an open base end and an apex end;
a placement tool for maintaining said open base end in a configuration for passing said open base end over said surface of said heart.
According to the present invention, there is also provided a system for cardiac reinforcement comprising:
a cardiac reinforcement device comprising:
rs 2d (a) a biomedical material having an apical end and a base end and which generally conforms to an external geometry of a patient's heart;
(b) said biomedical material comprising a plurality of open cells, each open cell defined by multiple sides, each open cell sharing at least one of said multiple sides with an adjacent open cell;
(c) said biomedical material having a size selected to surround said external geometry of said heart and constrain cardiac expansion; and a placement tool for maintaining said base end of said cardiac reinforcement device in an open position for passing said cardiac reinforcement device over said external geometry of said heart.
According to the present invention, there is also provided a cardiac reinforcement device for constraining outward expansion of a heart wall of a patient's heart during diastole, said device comprising:
(a) a biomedical material having an apical end and a base end and which generally conforms to an external geometry of said patient's heart;
(b) said biomedical material being elastic and having a compliance lower than a compliance of said heart wall;
(c) said biomedical material comprising a size selected to surround an external surface of said heart and constrain cardiac expansion during diastole.
According to the present invention, there is also provided a cardiac reinforcement device for constraining cardiac size during diastole, said device comprising:
(a) an elastic biomedical material for contacting an epicardial surface of a patient's heart and configured to 2e circumferentially surround said epicardial surface of said patient's heart;
(b) said biomedical material comprising a plurality of open cells, each open cell defined by multiple sides, each open cell sharing at least one of said multiple sides with an adjacent cell;
(c) said configured biomedical material having a base end and an apical end and formed into a jacket to surround said heart with said jacket having an internal volume to receive said heart;
(d) said configured biomedical material being less compliant than a wall of said heart; and (e) said configured biomedical material providing cardiac constraint during diastole without substantially assisting cardiac contraction during systole.
According to the present invention, there is also provided a cardiac reinforcement device, said device comprising:
(a) a jacket of a biomedical material which can be applied to an epicardial surface of a patient's heart and which expands to a size selected to surround said epicardial surface of said heart and circumferentially constrain cardiac expansion, said jacket comprising:
i) a base end, said base end having an opening for applying said jacket to said epicardial surface of said heart by passing said jacket over said epicardial surface of said heart such that when applied to said epicardial surface, said base end of said jacket is oriented toward a base of said heart; and ii) said biomedical material being elastic and having a compliance less than a wall of said heart.
2f According to the present invention, there is also provided a cardiac reinforcement device for constraining cardiac size during diastole, said device comprising:
(a) a biomedical material for contacting an epicardial surface of a patient's heart and configured to circumferentially surround said epicardial surface of said patient's heart;
(b) said biomedical material comprising a plurality of open cells, each open cell defined by multiple sides, each open cell sharing at least one of said multiple sides with an adjacent cell;
(c) said configured biomedical material having a base end and an apical end and formed into a jacket to surround said heart with said jacket having an internal volume to receive said heart;
(d) said configured biomedic-al material being elastic; and (e) said configured biomedical material providing cardiac constraint during diastole without substantially assisting cardiac during systole.
According to the present invention, there is also provided a passive cardiac reinforcement device for constraining outward expansion of a heart wall of a patient's heart during diastole, said device comprising:
(a) a jacket constructed from a biomedical material, said jacket having an apical end and a base end and a size selected to surround an external surface of said heart and constrain cardiac expansion during diastole without substantially assisting cardiac contraction during systole;
and (b) a marker for evaluating cardiac performance.
2g According to another aspect of the present inven-tion, there is provided a method for treating cardiac disease, said method comprising:
(a) selecting a cardiac reinforcement device, said cardiac reinforcement device comprising:
i) a substantially non-elastic biomedical material which can be applied to an epicardial surface of said heart and having a maximum predetermined size, said predetermined size selected to constrain cardiac expansion beyond a predetermined limit;
ii) said substantially non-elastic biomedical material comprising a plurality of continuous strands of said biomedical material, said strands defining a plurality of open cells;
(b) applying said cardiac reinforcement device to said surface of said heart by applying said device to dia-metrically opposite sides of said heart and with opposite sides of said biomedical material overlying said opposite sides of said heart interconnected to one another; and (c) securing said cardiac reinforcement device to said surface of said heart with said opposing sides urged together by a spacing less than an unconstrained diastolic expansion of said diametrically opposite sides of said heart.
According to another aspect of the present inven-tion, there is provided a method for treating cardiac disease, said method comprising:
(a) selecting a cardiac reinforcement device, said cardiac reinforcement device comprising:
i) a synthetic biomedical material which can be applied to an epicardial surface of a patient's heart and 2h having a maximum pre-determined size, said predetermined size selected to constrain cardiac expansion beyond a predetermined limit;
ii) said synthetic biomedical material compri-sing a continuous mesh construction, said continuous mesh construction defining a plurality of open cells;
iii) said synthetic biomedical material formed into a jacket to surround said heart with said jacket having an internal volume to receive said heart;
(b) applying said cardiac reinforcement device to said surface of said heart; and (c) securing said cardiac reinforcement device to said surface of said heart with said jacket adjusted for said internal volume to assume said maximum predetermined size.
According to another aspect of the present invention, there is provided a method for reducing dias-tolic volume of a patient's heart, said method comprising:
(a) selecting a cardiac reinforcement device, said cardiac reinforcement device comprising:
i) a substantially non-elastic biomedical material which can be applied to an epicardial surface of said heart and having a maximum predetermined size, said predetermined size selected to constrain cardiac expansion beyond a predetermined limit, said cardiac reinforcement device configured into a jacket, said jacket having an open base end and an apical end;
(b) mounting said cardiac reinforcement device to a place ment tool which maintains said open base end in a configuration for passing said open base end over said epicardial surface of said heart;
2i (c) applying said cardiac reinforcement device to said surface of said heart; and (d) securing said cardiac reinforcement device to said epicardial surface of said heart.
According to another aspect of the present inven-tion, there is provided a method for minimally invasive treatment of cardiac disease of a patient's heart, said method comprising:
(a) making a first and second minimally invasive incision into said patient's thorax;
(b) passing a thorascope into said first incision for intra-thoracic visualization;
(c) passing a cannula into said second incision to a posi-tion for applying a cardiac reinforcement device to said patient's heart, wherein said cardiac reinfor-cement device comprises:
i) a biomedical material which can be applied to an epicardial surface of said heart and having a maximum predetermined size, said predetermined size selected to surround said surface of said heart and circumferentially constrain cardiac expansion beyond a predetermined limit;
(d) applying said cardiac reinforcement device to said epicardial surface of said patient's heart;
(e) removing said thorascope from said patient's thorax;
(f) closing said first and said second incisions in said patient's thorax.
A cardiac reinforcement device of the invention can be used to treat cardiomyopathy or to reduce the dias-tolic volume of the heart.
2j Brief Description of the Drawings FIG.1 is a frontal view of one embodiment of a cardiac reinforcement patch.
FIG.2 is a perspective view of the cardiac reinforcement patch of Fig.l in place on the epicardium of a heart.
FIG.3 is a perspective view of one embodiment of a cardiac reinforcement jacket according to the invention.
WO 98!14136 PCT/US97/17898 FIG. 4 is a second embodiment of a cardiac reinforcement jacket according to the invention.
FIG. 5 is a perspective view of the embodiment of the cardiac reinforcement jacket shown in FIG. 3 in place aground the heart.
FIG. 6 is a schematic cross sectional view of one embodiment of a mechanism for selectively adjusting the predete;rmined size of a cardiac reinforcement jacket.
FIG. 7 is a perspective view of a, placement tool which can be used for applying a cardiac reinforcement jacket.
FIG. 8 is a perspective view of a. placement tool being employed to place a cardiac reinforcement jacket over the he;art.
Detailed Descri i n The present invention is directed to reinforcement of the heart wall during diastolic filling of a chamber of the heart. The invention is particularly suited for use in cardiomyopathies where abnormal dilation of one or more chambers of the heart is a component of the disease.
As used herein, "cardiac chamber" refers to the left or right atrium or the left or right ventricle. The term "myocardium" refers to the cardiac muscle comprising the contractile walls of the heart. The term "endocardial surface"
refers to the inner walls of the heart. The term "epicardial surface" refers to the outer walls of the heart.
The heart is enclosed within a double walled sac known as the pericardium. The inner layer of the pericardial sac is the visceral pericardium or epicardium. The outer layer of the pericardial sac is the parietal pericardium.
According to the present invention, a cardiac reinforcement device (CRD) limits the outward expansion of the hea~~t wall during diastolic chamber filling beyond a predetermined size. The expansion constraint applied to the heart by a CRD is predetermined by the physician based on, for example, cardiac output performance or cardiac volume. In contrast to known ventricular assist devices which provide cardiac assistance during systole, a CRD according to the present disclosure provides cardiac reinforcement during diastole.
A CRD is made from a biomedical material which can be applied to the epicardial surface of the heart. As used herc;in, a "biomedical material"
is a material which is physiologically inert to avoid rejection or other negative inflammatory response. A CRD can be prepared from an elastic or substantially non-elastic biomedical material. The biomedical material can be inflexible, but is preferably sufficiently flexible to move with the; expansion and contraction of the heart without impairing systolic function. The biomedical material should, however, constrain cardiac expansion, during diastolic filling of the heart, to a predetermined size. Examples of suitable biomedical materials include perforate and non-perforate materials. Perforate materials include, for example, a mesh such as a polypropylene or polyester mesh. Non-perforate materials include, for example, silicone rubber.
A biomedical material suitable for a device of the invention generally has a lower compliance than the heart wall. Even though the biomedical material is less compliant than the heart wall, some limited expansion of an elastic biomedical material can occur during cardiac filling.
In an alternative embodiment, the biomedical material can be substantially non-elastic. According to this embodiment, the term "substantially non-elastic" refers to a material which constrains cardiac expansion during diastole at a predetermined size, but which has substantially no elastic properties.
Regardless if the biomedical material is elastic or non-elastic, advantageous to a CRD according to the present disclosure is cardiac reinforcement which is provided during diastole. Moreover, a CRD as disclosed herein does not provide cardiac assistance through active pumping of the heart.
I. CRD Patch In one embodiment, a cardiac reinforcement device (CRD) provides for local constraint of the heart wall during cardiac expansion. According to this embodiment, a CRD is a "patch" that provides reinforcement of the heart wall at a localized area, such as a cardiac aneurysm or at an area of the myocardium which has been damaged due to myocardial infarction. When discussing a "patch", "predetermined size" of the patch means that the size of the patch is selected to cover an area of the epicardial surface of the heart in need of reinforcement without completely surrounding the circumference of the heart.
A CRD patch can be prepared from the biomedical materials described above. In a preferred embodiment, the patch is an open mesh material.
A CRD patch can be applied to the epicardial surface of the heart over or under the parietal pericardium. A patch is typically applied to the epicardial surface by suturing around the periphery of the patch. The peripheral edge of the patch can include a thickened "ring" or other reinforcement to enhance the strength of the patch at the point of suture attachment to the epicardium. Generally, a patch is applied to the epicardium through a thoracotomy or other incision providing sufficient exposure of the heart.
WO 98/14136 PCTlUS97/17898 II. CRD Jacket In another embodiment, a CRD is a jacket that circumferentially surrounds the epicardial surface of the heart. V~Jhen applied to the heart, a CRD
jacket can be placed over or under the parietal pericardium.
A CRD applied to the epicardimn is fitted to a "predetermined size"
for limitation of cardiac expansion. According to a jacket embodiment, "predetermined size" refers to the predetermined expansion limit of the jacket which circumferentially constrains cardiac expansion during diastolic filling of the heart.
In practice, for example, a physician could measure cardiac output and adjust the jacket size to an optimal size for the desired effect. In this example, the optimal size is the "predetermined size". In one embodiment, the predetermined size can be adjusted for size reduction as the cardiac size is, reduced.
In one embodiment, the CRD jacket is a cone-shaped tube, having a base broader than the apex, which generally conforms to the external geometry of the heart. When applied to the epicardial surface of the heart, the base of the jacket is oriented towards the base of the heart, and the apex of the jacket is oriented towards the apex of the heart. Typically, the base of the jacket includes an opening for applying the jacket by passing the jacket over the epicardial surface of the heart.
The apical end of the jacket can be a continuous surface which covers the apex of the heart. Alternatively, the apex of the jacket can have an opening through which the apex of the heart protrudes.
A cardiac reinforcement jacket, .as disclosed herein, is not an inflatable device that surrounds the heart. Rather, the device is typically a single layer of biomedical material. In one embodiment discussed below, an inflatable member can be included with the device, but the inflatable member serves to reduce the volume within a localized region of the jacket and does not follow the entire jacket to surround the epicardial surface of the heart.
In one embodiment, the CRD jacket can be secured to the epicardium by a securing arrangement mounted at the base of the jacket. A suitable securing arrangement includes, for example, a circumferential attachment device, such as a cord, suture, band, adhesive or shape memory element which passes around the circumference of the base of the jacket. The ends of the attachment device can be fastened together to secure the jacket in place. Alternatively, the base of the jacket can be reinforced for suturing the base of the jacket to the epicardium.
Various sized CRD jackets can be prepared such that different sized jackets are used for different predetermined cardiac expansion sizes or expansion ranges. Alternatively, a CRD jacket can include a mechanism for selectively adjusting the size of the jacket. A mechanism for selectively adjusting the volumetric size of the jacket theoretically provides for a "one size fits all"
device.
More importantly, however, an adjustable jacket provides the ability to titrate (readjust) the amount of cardiac reinforcement by graded reduction in jacket size as therapeutic reduction of cardiac expansion occurs.
A mechanism for selectively adjusting the size of the jacket can include a slot which opens at the base of the jacket and extends toward the apex end of the CRD. If the apex end of the CRD jacket is open, the apical extent of the slot can be continuous with the apex opening. The slot includes opposing lateral edges.
By adjusting the proximity of the opposing lateral edges, the overall size of the jacket can be varied. Moving the opposing edges of the slot closer together narrows the slot and reduces the volumetric size of the jacket. The opposing edges of the slot can be fastened together at a predetermined proximity by, for example, one or more lateral attachment devices, such as a cord, suture, band, adhesive or shape memory element attached to each lateral edge.
In another embodiment, a mechanism for selectively adjusting the size of the jacket can be an inflatable member. According to this embodiment, the inflatable member is mounted between the jacket and the epicardium. The volumetric size of the jacket can be reduced by inflating the inflatable member through an inflation port with, for example, a gas or liquid. As cardiac expansion volume responds to cardiac constraint by size reduction, the predetermined size of the jacket can then be reduced by inflating the inflatable member within the jacket.
Once inflated, the size of the inflatable member is preferably maintained until therapeutic response causes a need for further inflation. According to the invention, the inflation of the inflatable member provides a reduction in the predetermined size of the jacket by a fixed increase in volume of the inflatable member. The inflatable member is not rhythmically inflated and deflated to provide assistance to cardiac contraction during systole.
The biomedical material of the invention can be radioluscent or radiopaque. In one embodiment, the material of the jacket can be made radiopaque by inclusion of radiopaque markers for identification of the outside surface of the heart, the expansion slot or inflation port. As used herein, radiopaque means causing the CRD to be visible on x-ray or fluoroscopic viewing. Suitable radiopaque markers include, for example, platinum wires, titanium wires and stainless steel cores.
A CRD according to the present disclosure provides a new method for the treatment of cardiac disease. As used herein, cardiac disease includes diseases in which dilation of one of the chambers of the heart is a component of the disease. Examples include heart failure or cardiomyopathy. Heart failure can occur as a result of cardiac dilation due to ventricular hypertrophy or secondary to, for example, valvular incompetency, valvular insufficiency or valvular stenosis.
Cardiomyopathy, according to the invention, can be primary or secondary to infection, ischemia, metabolic disease, genetic disorders, etc.
It is foreseen that constraint of c~~rdiac expansion by a device of the invention can provide reduced cardiac dilation. Reduced cardiac dilation can cause reduction in the problems associated with cardiac dilation such as arrhythmias and valvular leakage. As reduction of cardiac dilation occurs, selective reduction of the predetermined size of the jacket also provides continued reinforcement for the size reduced heart.
A CRD jacket can also be used to measure cardiac performance.
According to this embodiment, the CRD jacket is rendered radiopaque by use of a radiographic marker. The radiographic markers are distributed throughout the jacket over the surface of the heart. By evaluation of the markers relative to one another with each heart beat, cardiac performance may be measured. As such, evaluation of cardiac performance may assist in adjusting the predetermined size of a CRD
jacket.
A CRD as described herein can be applied to the epicardium of a heart through a thoracotomy or through a minirr.~ally invasive procedure. For a minimally invasive procedure a CRD placement: tool can be used to apply the CRD
over the epicardium of the heart through a thorascopic incision. According to this embodiment, a CRD placement tool includes a c;annula, a stiff rod or wire and a guide tube. For placement of a CRD, the wire is threaded through the guide tube which is passed around the circumference of the base of the jacket. The CRD
with wire and guide tube passed through the base opening are then passed into the cannula. The cannula is of sufficient length and diameter to enclose the CRD, wire and guide tube during passage of the placement tool through a thorascopic incision.
The placement tool is passed into the thoracic cavity and positioned at a point near the apex of the heart. When in position, the wire and guide tube are pushed out of the cannula away from the operator. Once outside the cannula, the wire and guide tube sufficiently expand the opening of the base of the CRD jacket to pass over the epicardial surface of the heart. When the CRD jacket is in position over the epicardial surface, the wire, guide tube and cannula can be removed. A second incision can then be made to provide access for ;suitable surgical instruments to secure or adjust the size of the CRD.
The invention will now be further described by reference to the drawings.
FIG. I is a frontal view of one embodiment of a cardiac reinforcement patch 1. The CRD patch 1 shown. here is a mesh biomedical material 2 having a thickened peripheral ring 3 which reinforces the peripheral edge 4 of the patch for attachment of the patch to the epicardial surface of the heart.
FIG. 2. is a perspective view of a CRD patch 10 in place on the epicardial surface of a heart 11, for example, over a cardiac aneurysm (not shown) of the heart. In one preferred embodiment, the patch 10 is sized to cover the extent of the cardiac aneurysm and is placed on the epicardial surface of the heart 11.
In practice, the thorax is surgically opened and the region of the heart 11 with the aneurysm (not shown) is located and exposed. The patch 10 is placed over the aneurysm and sutured in place around the periphery 12 of the patch to provide sufficient constraint to prevent further dilation of the aneurysm.
FIG. 3 is a perspective view of one embodiment of a CRD jacket 15 according to the invention. According to the embodiment shown, the jacket 15 is a mesh material 16, and includes a circumferential attachment device 17 at the base end 18 of the CRD jacket. The apex end 24 of the jacket 15 is closed. The jacket 15 shown also includes a slot 19 having opposing lateral edges 20 and 21, and fasteners (e.g. lateral attachment device 22 and 23) for selectively adjusting the volumetric size of the jacket 15. The CRD jacket 15 shown also includes radiopaque markers for visualizing the surface of the heart through radiographic study.
FIG. 4 is an alternative embodiment of a CRD jacket 30. Similar to 20 the embodiment shown in FIG. 3, the embodiment of FIG. 4 includes a base end 31 and an apex 32 end. The base end includes a circumferential attachment device for securing the CRD jacket 30 to the heart. The CRD jacket 30 of FIG. 4 also includes a slot 34 having opposing lateral edges 35, 36. The lateral edges 35, 36 are shown pulled together at 37 by a lateral attachment device 38, for example, a suture.
25 In contrast to the embodiment shown in FIG. 3, the embodiment shown in FIG.
has an opening 39 at the apex end 32 of the CRD jacket 30.
FIG. 5. is a perspective view of a CRD jacket 40 around a heart 41.
According to the embodiment shown, at the base 42 of the jacket 40, there is a circumferential attachment device 43 which secures the CRD jacket 40 near the base of the heart 44. A slot 45, is shown with opposing lateral edges 46, 47 fastened together by a lateral attachment device 48. In the embodiment shown, the CRD
jacket 40 has an opening 49 at the apical end 50 of the jacket. The apex of the heart 51 protrudes through the opening 49 at the apical end 50 of the jacket 40.
Still referring to FIG. S, in a preferred embodiment, if one or more of the lateral attachment device 48 are made of an elastic material, such as silicone rubber, the device can provide a way of applying a graded constraint around the outside of the heart 41 to reduce cardiac dilation over time. In practice, the jacket would be placed over the heart 41 as shown, either over or under the parietal pericardium (not shown). The circumferential attachment device 43 and lateral attachment device 48 would then be tightened to cause a constraining effect on the outside of the heart.
In a preferred embodiment, if one or more of the lateral attachment cords 48 is made of an elastic material, such as silicone rubber, surface pressure exerted on the epicardial surface of the heart v~u-ies as a function of the amount of dilation of the heart. This variable pressure ha;~ the effect of reducing the cardiac dilation to a certain point and then stopping because the surface pressure drops to a negligible amount. The amount of constraint or reduction in dilation that is accomplished over time and the resultant cardiac performance may be monitored radiographically using techniques known in the: art, for example fluoroscopy, by observing radiographic markers (FIG. 4, 25), if' present.
FIG. 6 is a schematic cross sectional view of an alternative embodiment of an arrangement for selectively adjusting the predetermined size of a jacket 53. According to this embodiment, an inflatable member 54 is inserted within the jacket 53 between the jacket 53 and the epi<;ardial surface 55 of the heart 56.
The inflatable member 54 includes a filling apparatus 57 for entry of a fluid (liquid or gas) to inflate the inflatable member 54 and reduce the predetermined size of the jacket 53.
FIG. 7 is a perspective view of a. placement tool 60 which can be used for placement of a CRD jacket 61 around the epicardium of the heart. As shown here, the base end of the jacket 62 is held open by guide tube 63 through which is passed a wire or stiffening rod 64. The wire 64 can be removed from the guide tube 63 by pulling on the wire extraction grip 66. The placement tool 60 includes a cannula 65 which encloses the jacket 61, guide tube 63 and wire 64 during insertion of the tool into a thorascopic incision.
FIG. 8 is a perspective view of a placement tool 70 being employed to place a jacket 71 over the heart 72 on the outside of the parietal pericardium 73.
The placement tool 70 is guided through a small incision in the thorax and the jacket 71 is maneuvered into position over the heart 72. Once the jacket 7i is in proper position, the wire 74, which is passed through tl:~e guide tube 75 around the base 76 of the jacket 71, is extracted from the guide tube 75 by pulling on the wire extraction grip 77. The guide tube 75 is then extracted by pulling on the guide tube extraction grip 78. The cannula 79 is removed from the chest and the circumferentiai attachment cord (not shown in this view), and the lateral attachment cord 80 can be fastened to secure the jacket 71.
The above specification and drawings provide a description of a cardiac reinforcement device and method of using on the heart. Since many embodiments of the invention can be made without departing from the spirit and scope of the invention, the invention resides in the claims hereinafter appended.
Claims (83)
1. A cardiac reinforcement device comprising:
(a) a biomedical material having an apical end and a based end and which generally conforms to the external geometry of a patient's heart;
(b) said biomedical material being elastic and comprising a plurality of open cells, each open cell defined by multiple sides, each open cell sharing at least one of said multiple sides with an adjacent open cell; and (c) said biomedical material being a size selected to surround the surface of the heart and constrain cardiac expansion.
(a) a biomedical material having an apical end and a based end and which generally conforms to the external geometry of a patient's heart;
(b) said biomedical material being elastic and comprising a plurality of open cells, each open cell defined by multiple sides, each open cell sharing at least one of said multiple sides with an adjacent open cell; and (c) said biomedical material being a size selected to surround the surface of the heart and constrain cardiac expansion.
2. The cardiac reinforcement device according to claim 1, wherein said biomedical material is a mesh.
3. The cardiac reinforcement device according to any one of claims 1 and 2, wherein said biomedical material has a lateral slot providing for selective adjustment of a circumference of said biomedical material to said size.
4. The cardiac reinforcement device according to any one of claims 1 to 3, wherein said apical end of said device is open.
5. The cardiac reinforcement device according to any one of claims 1 to 4, wherein said biomedical material is a polyester mesh.
6. The cardiac reinforcement device according to any one of claims 1 to 5, wherein said base end of said biomedical material includes a securing arrangement for securing said device to said patient's heart.
7. The cardiac reinforcement device of any one of claims 1 to 6, further comprising an inflatable member sized for selectively adjusting said size of said biomedical material, said inflatable member sized for positioning between said device and said patient's heart.
8. A cardiac reinforcement device for constraining cardiac size during diastole, said device comprising:
(a) an elastic biomedical material for contacting an epicardial surface of a patient's heart and configured to circumferentially surround said epicardial surface of said patient's heart;
(b) said configured biomedical material having a base end and an apical end and formed into a jacket to surround the heart with the jacket having an internal volume to receive said heart;
(c) said elastic biomedical material comprising a continuous mesh construction, said continuous mesh construction defining a plurality of open cells; and (d) said configured biomedical material providing cardiac constraint during diastole without substantially assisting cardiac contraction during systole.
(a) an elastic biomedical material for contacting an epicardial surface of a patient's heart and configured to circumferentially surround said epicardial surface of said patient's heart;
(b) said configured biomedical material having a base end and an apical end and formed into a jacket to surround the heart with the jacket having an internal volume to receive said heart;
(c) said elastic biomedical material comprising a continuous mesh construction, said continuous mesh construction defining a plurality of open cells; and (d) said configured biomedical material providing cardiac constraint during diastole without substantially assisting cardiac contraction during systole.
9. The cardiac reinforcement device according to claim 8, wherein said configured biomedical material has a lateral slot for providing selective adjustment of a circumference of said biomedical material to a size.
10. The cardiac reinforcement device according to claim 9, wherein said slot has opposing lateral edges which decrease said size of said circumference of said biomedical material by moving said opposing lateral edges together.
11. The cardiac reinforcement device according to any one of claims 8 to 10, wherein said apical end of said device is open.
12. The cardiac reinforcement device according to any one of claims 8 to 11, wherein said biomedical material is a polyester mesh.
13. The cardiac reinforcement device according to any one of claims 8 to 12, further comprising an inflatable member sized for selectively adjusting said size of said biomedical material, said inflatable member sized for positioning between said biomedical material and said patient's heart.
14. A cardiac reinforcement device for treating a cardiac condition, said device comprising:
(a) a synthetic biomedical material having interconnected sides with a predetermined maximum spacing between said sides which can be disposed on diametrically opposed surfaces of a heart;
(b) said synthetic biomedical material comprising an elastic, continuous mesh construction, said continuous mesh construction defining a plurality of open cells;
(c) said biomedical material having a base end and an apical end; and (d) said biomedical material providing cardiac constraint during diastole without substantially assisting cardiac contraction during systole.
(a) a synthetic biomedical material having interconnected sides with a predetermined maximum spacing between said sides which can be disposed on diametrically opposed surfaces of a heart;
(b) said synthetic biomedical material comprising an elastic, continuous mesh construction, said continuous mesh construction defining a plurality of open cells;
(c) said biomedical material having a base end and an apical end; and (d) said biomedical material providing cardiac constraint during diastole without substantially assisting cardiac contraction during systole.
15. The cardiac reinforcement device according to claim 14, wherein the biomedical material circumferentially surrounds the heart.
16. A cardiac reinforcement device, said device comprising:
a jacket of a biomedical material which can be applied to the epicardial surface of the heart and which expands to a size to surround the epicardial surface of the heart and circumferentially constrain cardiac expansion, said jacket comprising:
i) a base end, said base end having an opening for applying said jacket to the epicardial surface of the heart by passing said jacket over the epicardial surface of the heart such that when applied to said epicardial surface, said base end of said jacket is oriented toward the base of the heart; and ii) a slot for selectively adjusting said size of said jacket, said slot having opposing lateral edges which decrease said size of said jacket by moving said opposing lateral edges together.
a jacket of a biomedical material which can be applied to the epicardial surface of the heart and which expands to a size to surround the epicardial surface of the heart and circumferentially constrain cardiac expansion, said jacket comprising:
i) a base end, said base end having an opening for applying said jacket to the epicardial surface of the heart by passing said jacket over the epicardial surface of the heart such that when applied to said epicardial surface, said base end of said jacket is oriented toward the base of the heart; and ii) a slot for selectively adjusting said size of said jacket, said slot having opposing lateral edges which decrease said size of said jacket by moving said opposing lateral edges together.
17. The cardiac reinforcement device according to claim 16, wherein said biomedical material is elastic.
18. The cardiac reinforcement device according to any one of claims 16 or 17, including a lateral attachment device for fastening together said lateral opposing edges of said slot.
19. The cardiac reinforcement device according to any one of claims 16 to 18, further comprising an inflatable member mounted between said jacket and the epicardial surface for selectively adjusting said size of said jacket.
20. The cardiac reinforcement device according to any one of claims 16 to 19, wherein said biomedical material is an open mesh material.
21. The cardiac reinforcement device according to any one of claims 16 to 20, wherein said biomedical material is a polyester mesh.
22. The cardiac reinforcement device according to any one of claims 16 to 21, wherein said biomedical material is silicon rubber.
23. The cardiac reinforcement device according to any one of claims 16 to 21, wherein said biomedical material includes a radiopaque marker.
24. The cardiac reinforcement device according to claim 23, wherein said radiopaque marker is a platinum wire.
25. A cardiac reinforcement device, said device comprising:
a jacket of an open mesh biomedical material which can be applied to the epicardial surface of the heart and which expands to a size to surround the epicardial surface of the heart and circumferentially constrain cardiac expansion, said jacket comprising:
i) a base end, said base end having an opening for applying said jacket to the epicardial surface of the heart by passing said jacket over the epicardial surface of the heart such that when applied to said epicardial surface, said base end of said jacket is oriented toward the base of the heart; and ii) an inflatable member mounted between said jacket and the epicardial surface of the heart for selectively adjusting said size of said jacket.
a jacket of an open mesh biomedical material which can be applied to the epicardial surface of the heart and which expands to a size to surround the epicardial surface of the heart and circumferentially constrain cardiac expansion, said jacket comprising:
i) a base end, said base end having an opening for applying said jacket to the epicardial surface of the heart by passing said jacket over the epicardial surface of the heart such that when applied to said epicardial surface, said base end of said jacket is oriented toward the base of the heart; and ii) an inflatable member mounted between said jacket and the epicardial surface of the heart for selectively adjusting said size of said jacket.
26. The cardiac reinforcement device according to claim 25, wherein said biomedical material is elastic.
27. The cardiac reinforcement device according to any one of claims 25 or 26, wherein said biomedical material is a polyester mesh.
28. The cardiac reinforcement device according to any one of claims 25 to 27, wherein said biomedical material is silicon rubber.
29. The cardiac reinforcement device according to any one of claims 25 to 28, wherein said biomedical material includes a radiopaque marker.
30. The cardiac reinforcement device according to claim 29, wherein said radiopaque marker is a platinum wire.
31. An arrangement for placing a cardiac reinforcement device onto a heart comprising:
a cardiac reinforcement device, said cardiac reinforcement device comprising:
i) a biomedical material which can be applied to a surface of said heart and having a size selected to constrain cardiac expansion, said cardiac reinforcement device configured into a jacket, said jacket having an open base end and an apex end;
a placement tool for maintaining said open base end in a configuration for passing said open base end over said surface of said heart.
a cardiac reinforcement device, said cardiac reinforcement device comprising:
i) a biomedical material which can be applied to a surface of said heart and having a size selected to constrain cardiac expansion, said cardiac reinforcement device configured into a jacket, said jacket having an open base end and an apex end;
a placement tool for maintaining said open base end in a configuration for passing said open base end over said surface of said heart.
32. The arrangement according to claim 31, wherein said placement tool includes a loop around which said open base end of said jacket can be applied to maintain said open base end of said jacket in a configuration for passing over said surface of said heart.
33. The arrangement according to claim 32, wherein said loop comprises a guide tube, said guide tube capable of passing around a circumference of said base end of said jacket.
34. The arrangement according to claim 33, wherein said loop further comprises a guide wire, said guide wire capable of passing through said guide tube at said base end of said jacket to selectively expand said open base end of said jacket into a configuration for passing over said surface of said heart.
35. The arrangement according to any one of claims 31 to 34, wherein said biomedical material is elastic.
36. The arrangement according to any one of claims 31 to 35, wherein said biomedical material comprises a plurality of open cells, each open cell defined by multiple sides, each open cell sharing at least one of said multiple sides with an adjacent open cell.
37. The arrangement according to any one of claims 31 to 36, wherein said biomedical material is a polyester mesh.
38. The arrangement according any one of claims 31 to 37, wherein said apex end of said cardiac reinforcement device is open.
39. The arrangement according to any one of claims 31 to 38, further comprising a cannula for insertion of said cardiac reinforcement device and said placement tool through a thorascopic incision.
40. A system for cardiac reinforcement comprising:
a cardiac reinforcement device comprising:
(a) a biomedical material having an apical end and a base end and which generally conforms to an external geometry of a patient's heart;
(b) said biomedical material comprising a plurality of open cells, each open cell defined by multiple sides, each open cell sharing at least one of said multiple sides with an adjacent open cell;
(c) said biomedical material having a size selected to surround said external geometry of said heart and constrain cardiac expansion; and a placement tool for maintaining said base end of said cardiac reinforcement device in an open position for passing said cardiac reinforcement device over said external geometry of said heart.
a cardiac reinforcement device comprising:
(a) a biomedical material having an apical end and a base end and which generally conforms to an external geometry of a patient's heart;
(b) said biomedical material comprising a plurality of open cells, each open cell defined by multiple sides, each open cell sharing at least one of said multiple sides with an adjacent open cell;
(c) said biomedical material having a size selected to surround said external geometry of said heart and constrain cardiac expansion; and a placement tool for maintaining said base end of said cardiac reinforcement device in an open position for passing said cardiac reinforcement device over said external geometry of said heart.
41. The system according to claim 40, wherein said biomedical material is elastic.
42. The system according to any one of claims 40 or 41, wherein said biomedical material has a lateral slot providing for selective adjustment of a circumference of said biomedical material to said size.
43. The system according to any one of claims 40 to 42, wherein said apical end of said cardiac reinforcement device is open.
44. The system according to any one of claims 40 to 43, wherein said biomedical material is a mesh material.
45. The system according to any one of claims 40 to 44, wherein said biomedical material is a polyester mesh.
46. The system according to any one of claims 40 to 45, wherein said base end of said biomedical material includes a securing arrangement for securing said device to said patient's heart.
47. The system according to any one of claims 40 to 44, wherein said placement tool includes a loop around which said base end of said cardiac reinforcement device can be applied to maintain said open base end of said cardiac reinforcement device in a configuration for passing over said external geometry of said heart.
48. The system according to claim 47, wherein said loop comprises a guide tube, said guide tube capable of passing around a circumference said base end of said cardiac reinforcement device.
49. The system according to claim 48, wherein said loop further comprises a guide wire, said guide wire capable of passing through said guide tube at said base end of said cardiac reinforcement device to selectively expand said base end of said cardiac reinforcement device to pass over said external geometry of said heart.
50. A cardiac reinforcement device for constraining outward expansion of a heart wall of a patient's heart during diastole, said device comprising:
(a) a biomedical material having an apical end and a base end and which generally conforms to an external geometry of said patient's heart;
(b) said biomedical material being elastic and having a compliance lower than a compliance of said heart wall;
(c) said biomedical material comprising a size selected to surround an external surface of said heart and constrain cardiac expansion during diastole.
(a) a biomedical material having an apical end and a base end and which generally conforms to an external geometry of said patient's heart;
(b) said biomedical material being elastic and having a compliance lower than a compliance of said heart wall;
(c) said biomedical material comprising a size selected to surround an external surface of said heart and constrain cardiac expansion during diastole.
51. The cardiac reinforcement device according to claim 50, wherein said biomedical material comprises a plurality of open cells, each open cell defined by multiple sides, each open cell sharing at least one of said multiple sides with an adjacent open cell.
52. The cardiac reinforcement device according to any one of claims 50 or 51, wherein said biomedical material has a lateral slot providing for selective adjustment of a circumference of said biomedical material to said size.
53. The cardiac reinforcement device according to any one of claims 50 to 52, wherein said apical end of said device is open.
54. The cardiac reinforcement device according to any one of claims 50 to 53, wherein said biomedical material is a mesh material.
55. The cardiac reinforcement device according to any one of claims 50 to 54, wherein said biomedical material is a polyester mesh.
56. The cardiac reinforcement device according to any one of claims 50 to 53, wherein said base end of said biomedical material includes a securing arrangement for securing said device to said patient's heart.
57. The cardiac reinforcement device according to any one of claims 50 to 56, further comprising an inflatable member sized for selectively adjusting said size of said biomedical material, said inflatable member sized for positioning between said device and said patient's heart.
58. A cardiac reinforcement device for constraining cardiac size during diastole, said device comprising:
(a) an elastic biomedical material for contacting an epicardial surface of a patient's heart and configured to circumferentially surround said epicardial surface of said patient's heart;
(b) said biomedical material comprising a plurality of open cells, each open cell defined by multiple sides, each open cell sharing at least one of said multiple sides with an adjacent cell;
(c) said configured biomedical material having a base end and an apical end and formed into a jacket to surround said heart with said jacket having an internal volume to receive said heart;
(d) said configured biomedical material being less compliant than a wall of said heart; and (e) said configured biomedical material providing cardiac constraint during diastole without substantially assisting cardiac contraction during systole.
(a) an elastic biomedical material for contacting an epicardial surface of a patient's heart and configured to circumferentially surround said epicardial surface of said patient's heart;
(b) said biomedical material comprising a plurality of open cells, each open cell defined by multiple sides, each open cell sharing at least one of said multiple sides with an adjacent cell;
(c) said configured biomedical material having a base end and an apical end and formed into a jacket to surround said heart with said jacket having an internal volume to receive said heart;
(d) said configured biomedical material being less compliant than a wall of said heart; and (e) said configured biomedical material providing cardiac constraint during diastole without substantially assisting cardiac contraction during systole.
59. The cardiac reinforcement device according to claim 58, wherein said biomedical material is a mesh.
60. The cardiac reinforcement device according to any one of claims 58 or 59, wherein said biomedical material is a polyester mesh.
61. The cardiac reinforcement device according to any one of claims 58 to 60, wherein said configured biomedical material has a lateral slot for providing selective adjustment of a circumference of said biomedical material to a size.
62. The cardiac reinforcement device according to claim 61, wherein said slot has opposing lateral edges which decrease said size of said circumference of said biomedical material by moving said opposing lateral edges together.
63. The cardiac reinforcement device according to any one of claims 58 to 62, wherein said apical end of said device is open.
64. A cardiac reinforcement device, said device comprising:
(a) a jacket of a biomedical material which can be applied to an epicardial surface of a patient's heart and which expands to a size selected to surround said epicardial surface of said heart and circumferentially constrain cardiac expansion, said jacket comprising:
i) a base end, said base end having an opening for applying said jacket to said epicardial surface of said heart by passing said jacket over said epicardial surface of said heart such that when applied to said epicardial surface, said base end of said jacket is oriented toward a base of said heart; and ii) said biomedical material being elastic and having a compliance less than a wall of said heart.
(a) a jacket of a biomedical material which can be applied to an epicardial surface of a patient's heart and which expands to a size selected to surround said epicardial surface of said heart and circumferentially constrain cardiac expansion, said jacket comprising:
i) a base end, said base end having an opening for applying said jacket to said epicardial surface of said heart by passing said jacket over said epicardial surface of said heart such that when applied to said epicardial surface, said base end of said jacket is oriented toward a base of said heart; and ii) said biomedical material being elastic and having a compliance less than a wall of said heart.
65. The cardiac reinforcement device according to claim 64, wherein said biomedical material comprises a continuous mesh construction, said continuous mesh construction defining a plurality of open cells.
66. The cardiac reinforcement device according to any one of claims 64 or 65, wherein said apical end of said device is open.
67. The cardiac reinforcement device according to any one of claims 64 to 66, wherein said biomedical material is a polyester mesh.
68. A cardiac reinforcement device for constraining cardiac size during diastole, said device comprising:
(a) a biomedical material for contacting an epicardial surface of a patient's heart and configured to circumferentially surround said epicardial surface of said patient's heart;
(b) said biomedical material comprising a plurality of open cells, each open cell defined by multiple sides, each open cell sharing at least one of said multiple sides with an adjacent cell;
(c) said configured biomedical material having a base end and an apical end and formed into a jacket to surround said heart with said jacket having an internal volume to receive said heart;
(d) said configured biomedical material being elastic; and (e) said configured biomedical material providing cardiac constraint during diastole without substantially assisting cardiac contraction during systole.
(a) a biomedical material for contacting an epicardial surface of a patient's heart and configured to circumferentially surround said epicardial surface of said patient's heart;
(b) said biomedical material comprising a plurality of open cells, each open cell defined by multiple sides, each open cell sharing at least one of said multiple sides with an adjacent cell;
(c) said configured biomedical material having a base end and an apical end and formed into a jacket to surround said heart with said jacket having an internal volume to receive said heart;
(d) said configured biomedical material being elastic; and (e) said configured biomedical material providing cardiac constraint during diastole without substantially assisting cardiac contraction during systole.
69. A passive cardiac reinforcement device for constraining outward expansion of a heart wall of a patient's heart during diastole, said device comprising:
(a) a jacket constructed from a biomedical material, said jacket having an apical end and a base end and a size selected to surround an external surface of said heart and constrain cardiac expansion during diastole without substantially assisting cardiac contraction during systole;
and (b) a marker for evaluating cardiac performance.
(a) a jacket constructed from a biomedical material, said jacket having an apical end and a base end and a size selected to surround an external surface of said heart and constrain cardiac expansion during diastole without substantially assisting cardiac contraction during systole;
and (b) a marker for evaluating cardiac performance.
70. The cardiac reinforcement device according to claim 69, wherein said biomedical material is elastic.
71. The cardiac reinforcement device according to any one of claims 69 to 70, wherein said biomedical material is a mesh material.
72. The cardiac reinforcement device according to any one of claims 69 to 71, wherein said biomedical material is a polyester mesh material.
73. The cardiac reinforcement device according to any one of claims 69 to 72, wherein said marker for evaluating cardiac performance comprises a radiopaque marker.
74. The cardiac reinforcement device according to claim 73, wherein said radiopaque marker is selected from the group consisting of platinum wire, titanium wire and stainless steel wire.
75. The cardiac reinforcement device according to any one of claims 69 to 72, wherein said marker for evaluating cardiac performance comprises a radioluscent marker.
76. The cardiac reinforcement device according to any one of claims 69 to 75, wherein said biomedical material comprises a plurality of open cells, each open cell defined by multiple sides, each open cell sharing at least one of said multiple sides with an adjacent open cell.
77. The cardiac reinforcement device according to any one of claims 69 to 76, wherein said apical end of said device is open.
78. The cardiac reinforcement device according to any one of claims 69 to 77, wherein said biomedical material comprises a continuous mesh construction, said continuous mesh construction defining a plurality of open cells.
79. The cardiac reinforcement device according to any one of claims 69 to 78, wherein said jacket further comprises a lateral slot for providing selective adjustment of a circumference of said jacket to a size.
80. The cardiac reinforcement device according to claim 79, wherein said slot has opposing lateral edges which decrease said size of said circumference of said biomedical material by moving said opposing lateral edges together.
81. The cardiac reinforcement device according to claim 73, wherein the radiopaque marker is included proximate the lateral slot.
82. The cardiac reinforcement device according to any one of claims 69 to 81, further comprising an inflatable member sized for selectively adjusting said size of said biomedical material, said inflatable member sized for positioning between said device and said patient's heart and an inflation port.
83. The cardiac reinforcement device of claim 82, wherein the radiopaque marker is included proximate the inflation port.
Priority Applications (1)
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CA002451964A CA2451964A1 (en) | 1996-10-02 | 1997-10-01 | Heart volume limiting device |
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US6042707A (en) * | 1998-05-22 | 2000-03-28 | Cvc Products, Inc. | Multiple-coil electromagnet for magnetically orienting thin films |
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1996
- 1996-10-02 US US08/720,556 patent/US5702343A/en not_active Expired - Lifetime
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1997
- 1997-09-23 US US08/935,723 patent/US6077218A/en not_active Expired - Lifetime
- 1997-09-23 US US08/935,440 patent/US6126590A/en not_active Expired - Lifetime
- 1997-10-01 AT AT97909962T patent/ATE284180T1/en not_active IP Right Cessation
- 1997-10-01 EP EP97909962A patent/EP0930856B1/en not_active Expired - Lifetime
- 1997-10-01 NZ NZ335051A patent/NZ335051A/en unknown
- 1997-10-01 CA CA002451964A patent/CA2451964A1/en not_active Abandoned
- 1997-10-01 DE DE29724206U patent/DE29724206U1/en not_active Expired - Lifetime
- 1997-10-01 DE DE69731890T patent/DE69731890T2/en not_active Expired - Lifetime
- 1997-10-01 CA CA002267104A patent/CA2267104C/en not_active Expired - Fee Related
- 1997-10-01 NZ NZ515821A patent/NZ515821A/en unknown
- 1997-10-01 AU AU47450/97A patent/AU723460B2/en not_active Ceased
- 1997-10-01 WO PCT/US1997/017898 patent/WO1998014136A1/en active IP Right Grant
- 1997-10-01 NZ NZ506663A patent/NZ506663A/en unknown
- 1997-10-02 AR ARP970104536A patent/AR013611A1/en unknown
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1999
- 1999-08-18 US US09/376,812 patent/US6165121A/en not_active Expired - Lifetime
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2000
- 2000-01-14 US US09/483,466 patent/US6165122A/en not_active Expired - Lifetime
- 2000-10-25 US US09/696,651 patent/US6375608B1/en not_active Expired - Lifetime
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2002
- 2002-02-25 US US10/084,806 patent/US6544168B2/en not_active Expired - Fee Related
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2003
- 2003-02-13 US US10/367,346 patent/US6893392B2/en not_active Expired - Fee Related
- 2003-09-23 US US10/668,460 patent/US7163507B2/en not_active Expired - Fee Related
- 2003-09-23 US US10/668,528 patent/US20040059181A1/en not_active Abandoned
- 2003-09-23 US US10/668,918 patent/US7166071B2/en not_active Expired - Fee Related
- 2003-09-26 US US10/672,226 patent/US7261684B2/en not_active Expired - Fee Related
- 2003-09-26 US US10/672,227 patent/US7255674B2/en not_active Expired - Fee Related
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2004
- 2004-03-05 US US10/794,320 patent/US7278964B2/en not_active Expired - Fee Related
- 2004-03-26 US US10/810,099 patent/US7351200B2/en not_active Expired - Fee Related
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2007
- 2007-05-18 US US11/750,623 patent/US20070225547A1/en not_active Abandoned
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